Quality Engineer – Process & CAPA Leader

Providien Thermoforming, LLC; San Diego, Northern (CA, KY); Hybrid; USD 75,000 - 110,000; Full time

Job summary

Providien Thermoforming, LLC is seeking a Quality Engineer I to provide quality leadership on the Value Stream Team and support quality tasks across thermoformed products, with emphasis on inspection, documentation, and process improvement.

The role requires a bachelor’s degree or 5+ years in engineering, ISO 13485 knowledge, and 3+ years in manufacturing. Travel is 15% and the environment is a manufacturing floor focused on safety and continuous improvement.

Qualifications

• Bachelor’s degree in engineering or sciences, or 5+ years of experience in a technical engineering role.
• Minimum of 3 years of experience in manufacturing.
• Experience in Root Cause Analysis (5 Whys, Fishbone, 8D).
• Knowledge of ISO 13485:2016 and related quality standards preferred.
• Background in medical device, aerospace, or plastics/thermoforming manufacturing industries preferred.
• ASQ CQE or CQPA certification preferred.
• Six Sigma Green Belt preferred.

Responsibilities

• Provide daily quality support to manufacturing, including inspection, assembly, packaging and shipping operations.
• Investigate nonconforming products, scrap, rework, and customer complaints; identify root cause and implement corrective actions.
• Lead or support CAPAs using tools such as 5 whys, fishbone diagrams, and process data analysis.
• Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records.
• Review production documentation for completeness, accuracy and compliance with GDP.
• Partner with manufacturing and engineering teams on process changes, validation activities, risk assessment and FAI.
• Use trend data, defects rates, and quality metrics to identify recurring issues and measure improvement.
• Participate in internal, customers and ISO 13485 audits; help prepare responses and close finding on time.
• Train and coach employees on quality requirements and procedures on the manufacturing floor.
• Develop and implement standards and methods for inspecting, testing, and evaluating thermoformed products and components.
• Review of customer specifications
• Participate in the design and process of FMEAs, Design of Experiments, PPAPs, Process/Product Capability Studies, and Product Liability Meetings.
• Continuously improve quality systems and processes.

Skills

Root Cause Analysis

Quality Assurance

Statistical Analysis

GD&T

Documentation

Process Improvement

Education

Bachelor's degree in engineering or sciences

ASQ CQE or CQPA preferred

Six Sigma Green Belt preferred

Tools

MS Office

SharePoint

ERP systems

Blueprint reading

Job description

Providien Thermoforming, LLC is seeking a Quality Engineer I to provide quality leadership on the Value Stream Team and support quality tasks across thermoformed products, with emphasis on inspection, documentation, and process improvement.

The role requires a bachelor’s degree or 5+ years in engineering, ISO 13485 knowledge, and 3+ years in manufacturing. Travel is 15% and the environment is a manufacturing floor focused on safety and continuous improvement.